NCT06132516Active, not recruiting
Effects of HIIT on HRV in Sub-acute Post-stroke Patients
Effect of a High-intensity Interval-training on "Heart Rate Variability" Prognostic Parameters in Early Post-stroke Patients: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 31 Dec 2025
Brief summary (registry, in English)
Objective. To assess the effect of innovative "High-Intensity Interval Training" (HIIT) on Heart Rate Variability, a strong biomarker of positive outcome after stroke. Design. A randomized controlled study with blinded assessment of the main criteria. Population. NIHSS\<20 post-stroke patients, hospitalized in secondary care stroke-units within the first 3 months (sub-acute phase). Selection. Eligibility test on a semi-recumbent cycloergometer Intervention. In addition to a standard neurorehabilitation program (3±1 sessions daily, including cognitive and occupational therapy, physiotherapy with strengthening-stretching exercises), the aerobic group will benefit from a HIIT procedure (HIIT group) with a semi-recumbent cycloergometer, for 6 weeks representing 16 sessions; while the non-aerobic group will undertake a "Low-Intensity Group-Gymnastic Training" (Control or LIGT Group) (=segmental strengthening-stretching and proprioceptive exercises mainly), with the same training volume and frequency for both groups. Main outcome measure. Standard Deviation of Normal-to-Normal RR intervals (SDNN) from 24h Holter-ECG recordings at W4, W8 and M6. Modifications in patients' medical management are expected, as generalization of AT in moderate to severe stroke patients at the sub-acute phase, with "Low volume HIIT" and simple devices.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 30 Oct 2023
- Start date
- 15 Mar 2024
- Primary completion date
- Sept 2027
- Lead sponsor
- Hôpital Léon Bérard
- Diseases
- Stroke
- NCT number
- NCT06132516
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 15 Mar 2024 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- diabetes mellitus complicated by neuropathy or autonomic dysfunction; or any other concomitant nervous system, cardiac or pulmonary disease possibly affecting the autonomic nervous system ie:
Other illness
- myocardial infarction\< 6 months,
- myocardial dysfunction as severe dilated or hypertrophic cardiomyopathy, class 3 and 4 heart failure,
- severe conduction abnormalities and arrhythmias, including chronic atrial fibrillation,
- severe cognitive impairment inconsistent with free, informed and written consent or questionnaire filling
Age
- age\<18 years-old
Other
- mechanical ventilation,
- beta-blockers with no alternative options, pharmacological mandatory treatment possibly affecting the autonomic nervous system and HRV.
Who the study is looking for
- first-ever hemispheric stroke, with consistent clinical and neuroimaging signs
- \<3 month
- NIHSS \<20 in acute care
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr BARTHOLOMEI MN Coordinator of this site? Confirm its status | Hyères | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.